Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2012, 45811-45814 [2011-19336]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45811-45814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0548]


Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 
2012

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates 
and payment procedures for fiscal year (FY) 2012 animal drug user fees. 
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by 
the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User 
Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees 
for certain animal drug applications and supplements, on certain animal 
drug products, on certain establishments where such products are made, 
and on certain sponsors of such animal drug applications and/or 
investigational animal drug submissions. This notice establishes the 
fee rates for FY 2012.

FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm 
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food 
and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240-
276-9718. For general questions, you may also e-mail the Center for 
Veterinary Medicine (CVM) at: cvmadufa@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four 
different kinds of user fees: (1) Fees for certain types of animal drug 
applications and supplements, (2) annual fees for certain animal drug 
products, (3) annual fees for certain establishments where such 
products are made, and (4) annual fees for certain sponsors of animal 
drug applications and/or investigational animal drug submissions (21 
U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or 
reduce fees (21 U.S.C. 379j-12(d)).
    For FY 2009 through FY 2013, the FD&C Act establishes aggregate 
yearly base revenue amounts for each of these fee categories. Base 
revenue amounts established for years after FY 2009 are subject to 
adjustment for workload. Fees for applications, establishments, 
products, and sponsors are to be established each year by FDA so that 
the revenue for each fee category will approximate the level 
established in the statute, after the level has been adjusted for 
workload.
    For FY 2012, the animal drug user fee rates are: $372,100 for an 
animal drug application; $186,050 for a supplemental animal drug 
application for which safety or effectiveness data is required and for 
an animal drug application subject to the criteria set forth in section 
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $7,935 for an annual 
product fee; $93,050 for an annual establishment fee; and $67,200 for 
an annual sponsor fee. FDA will issue invoices for FY 2012 product, 
establishment, and sponsor fees by December 31, 2011, and these 
invoices will be due and payable within 30 days of issuance of the 
invoice. The application fee rates are effective for applications 
submitted on or after October 1, 2011, and will remain in effect 
through September 30, 2012. Applications will not be accepted for 
review until FDA has received full payment of application fees and any 
other animal drug user fees owed.

II. Revenue Amount for FY 2012

A. Statutory Fee Revenue Amounts

    ADUFA II (Pub. L. 110-316 signed by the President on August 14, 
2008) specifies that the aggregate revenue amount for FY 2012 for each 
of the four animal drug user fee categories is $5,442,000 before any 
adjustment for workload is made. (See 21 U.S.C. 379j-12(b)(1) through 
(b)(4).)

B. Inflation Adjustment to Fee Revenue Amount

    The amounts established in ADUFA II for each year for FY 2009 
through FY 2013 include an inflation adjustment; so, no further 
inflation adjustment is required.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    For each FY beginning in FY 2010, ADUFA provides that fee revenue 
amounts shall be further adjusted to reflect changes in review workload 
(21 U.S.C. 379j-12(c)(1)).
    FDA calculated the average number of each of the five types of 
applications and submissions specified in the workload adjustment 
provision (animal drug applications, supplemental animal drug 
applications for which data with respect to safety or efficacy are 
required, manufacturing supplemental animal drug applications, 
investigational animal drug study submissions, and investigational 
animal drug protocol submissions) received over the 5-year period that 
ended on September 30, 2002 (the base years), and the average number of 
each of these types of applications and submissions over the most 
recent 5-year period that ended on June 30, 2011.
    The results of these calculations are presented in the first two 
columns of table 1 of this document. Column 3 reflects the percent 
change in workload over the two 5-year periods. Column 4 shows the 
weighting factor for each type of application, reflecting how much of 
the total FDA animal drug review workload was accounted for by each 
type of application or submission in the table during the most recent 5 
years. Column 5 of table 1 of this document is the weighted percent 
change in each category of workload, and was derived by multiplying the 
weighting factor in each line in column 4 by the percent change from 
the base years in column 3. At the bottom right of the table the sum of 
the values in column 5 is added, reflecting a total change in workload 
of negative 31 percent for FY 2012. This is the workload adjuster for 
FY 2012.

[[Page 45812]]



                                     Table 1--Workload Adjuster Calculation
                                      [Numbers may not add due to rounding]
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                                                 Column 1 5-                                           Column 5
                                                  year avg.     Column 2     Column 3     Column 4     Weighted
                Application type                    (base      Latest 5-     Percent     Weighting     percent
                                                    years)     year avg.      change       factor       change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADA's)..........         28.8         13.0          -55       0.0296           -2
Supplemental NADA's with Safety or Efficacy             23.4         11.2          -52       0.0234           -1
 Data..........................................
Manufacturing Supplements......................        366.6        427.6           17       0.1385            2
Investigational Study Submissions..............        336.6        215.8          -36       0.6023          -22
Investigational Protocol Submissions...........        292.4        173.8          -41       0.2063           -8
    FY 2012 Workload Adjuster..................  ...........  ...........  ...........  ...........          -31
----------------------------------------------------------------------------------------------------------------

    ADUFA specifies that the workload adjuster may not result in fees 
that are less than the fee revenue amount in the statute (21 U.S.C. 
379j-12(c)(1)(B)). Because applying the FY 2012 workload adjuster would 
result in fees less than the statutory amount, the workload adjustment 
will not be applied in FY 2012. As a result, the statutory revenue 
target amount for each of the four categories of fees remains at 
$5,442,000 with the new total revenue target for fees in FY 2012 being 
$21,768,000.

III. Adjustment for Excess Collections in Previous Years

    ADUFA II amended the annual offset provision of ADUFA I to require 
one offset when FY 2013 fees are set in August of 2012, if aggregate 
collections from FY 2009 through 2011 plus the amount of fees estimated 
to be collected for FY 2012 exceed aggregate appropriations over the 
same period (21 U.S.C. 379j-12(g)(4), as amended by ADUFA II). 
Therefore FDA is not offsetting for excess collections at this time.

IV. Application Fee Calculations for FY 2012

    The terms ``animal drug application'' and ``supplemental animal 
drug application'' are defined in section 739 of the FD&C Act (21 
U.S.C. 379j-11(1) and (2)).

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    The application fee must be paid for any animal drug application or 
supplemental animal drug application that is subject to fees under 
ADUFA and that is submitted on or after September 1, 2003. The 
application fees are to be set so that they will generate $5,442,000 in 
fee revenue for FY 2012. This is the amount set out in the statute and 
no adjustments are required for FY 2012. The fee for a supplemental 
animal drug application for which safety or effectiveness data are 
required and for an animal drug application subject to criteria set 
forth in section 512(d)(4) of the FD&C Act is to be set at 50 percent 
of the animal drug application fee. (See 21 U.S.C. 379j-
12(a)(1)(A)(ii), as amended by ADUFA II.)
    To set animal drug application fees and supplemental animal drug 
application fees to realize $5,442,000, FDA must first make some 
assumptions about the number of fee-paying applications and supplements 
the agency will receive in FY 2012.
    The agency knows the number of applications that have been 
submitted in previous years. That number fluctuates significantly from 
year to year. In estimating the fee revenue to be generated by animal 
drug application fees in FY 2012, FDA is assuming that the number of 
applications that will pay fees in FY 2012 will equal the average 
number of submissions over the four most recent completed years (FY 
2007-FY 2010). This may not fully account for possible year to year 
fluctuations in numbers of fee-paying applications, but FDA believes 
that this is a reasonable approach after 8 years of experience with 
this program.
    Over the 4 most recent completed years, the average number of 
animal drug applications that would have been subject to the full fee 
was 8.25. Over this same period, the average number of supplemental 
applications and applications subject to the criteria set forth in 
section 512(d)(4) of the FD&C Act that would have been subject to half 
of the full fee was 12.75.
    Thus, for FY 2012, FDA estimates receipt of 8.25 fee paying 
original applications and 12.75 fee-paying supplemental animal drug 
applications and applications subject to the criteria set forth is 
section 512(d)(4) of the FD&C Act which pay half of the full fee.

B. Fee Rates for FY 2012

    FDA must set the fee rates for FY 2012 so that the estimated 8.25 
applications that pay the full fee and the estimated 12.75 supplements 
and applications subject to the criteria set forth in section 512(d)(4) 
of the FD&C Act that pay half of the full fee will generate a total of 
$5,442,000. To generate this amount, the fee for an animal drug 
application, rounded to the nearest hundred dollars, will have to be 
$372,100, and the fee for a supplemental animal drug application for 
which safety or effectiveness data are required and for applications 
subject to the criteria set forth in section 512(d)(4) of the FD&C Act 
will have to be $186,050.

V. Product Fee Calculations for FY 2012

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The animal drug product fee (also referred to as the product fee) 
must be paid annually by the person named as the applicant in a new 
animal drug application or supplemental new animal drug application for 
an animal drug product submitted for listing under section 510 of the 
FD&C Act (21 U.S.C. 360), and who had an animal drug application or 
supplemental animal drug application pending at FDA after September 1, 
2003. (See 21 U.S.C. 379j-12(a)(2).) The term ``animal drug product'' 
is defined in 21 U.S.C. 379j-11(3). The product fees are to be set so 
that they will generate $5,442,000 in fee revenue for FY 2012. This is 
the amount set out in the statute and no adjustments are required for 
FY 2012.
    To set animal drug product fees to realize $5,442,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2012. FDA developed data on all animal drug products 
that have been submitted for listing under section 510 of the FD&C Act, 
and matched this to the list of all persons who had an animal drug 
application or supplement pending after September 1, 2003. As of July 
2011, FDA estimates that there are a total of 762 products submitted 
for listing by persons who had an animal drug application or 
supplemental animal drug application pending after September 1, 2003. 
Based on this, FDA estimates that a total of 762 products will be 
subject to this fee in FY 2012.

[[Page 45813]]

    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2012, FDA is again assuming that 10 percent of the 
products invoiced, or about 76, will not pay fees in FY 2012 due to fee 
waivers and reductions. Based on experience with other user fee 
programs and the first 8 years of ADUFA, FDA believes that this is a 
reasonable basis for estimating the number of fee-paying products in FY 
2012.
    Accordingly, the agency estimates that a total of 686 (762 minus 
76) products will be subject to product fees in FY 2012.

B. Product Fee Rates for FY 2012

    FDA must set the fee rates for FY 2012 so that the estimated 686 
products that pay fees will generate a total of $5,442,000. To generate 
this amount will require the fee for an animal drug product, rounded to 
the nearest 5 dollars, to be $7,935.

VI. Establishment Fee Calculations for FY 2012

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

    The animal drug establishment fee (also referred to as the 
establishment fee) must be paid annually by the person who: (1) Owns or 
operates, directly or through an affiliate, an animal drug 
establishment; (2) is named as the applicant in an animal drug 
application or supplemental animal drug application for an animal drug 
product submitted for listing under section 510 of the FD&C Act; (3) 
had an animal drug application or supplemental animal drug application 
pending at FDA after September 1, 2003; and (4) whose establishment 
engaged in the manufacture of the animal drug product during the fiscal 
year. (See 21 U.S.C. 379j-12(a)(3).) An establishment subject to animal 
drug establishment fees is assessed only one such fee per fiscal year. 
(See 21 U.S.C. 379j-12(a)(3).) The term ``animal drug establishment'' 
is defined in 21 U.S.C. 379j-11(4). The establishment fees are to be 
set so that they will generate $5,442,000 in fee revenue for FY 2012. 
This is the amount set out in the statute and no adjustments are 
required for FY 2012.
    To set animal drug establishment fees to realize $5,442,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2012. FDA developed data on all animal 
drug establishments and matched this to the list of all persons who had 
an animal drug application or supplement pending after September 1, 
2003. As of July 2011, FDA estimates that there are a total of 65 
establishments owned or operated by persons who had an animal drug 
application or supplemental animal drug application pending after 
September 1, 2003. Based on this, FDA believes that 65 establishments 
will be subject to this fee in FY 2012.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2012, FDA is assuming that 10 percent of the 
establishments invoiced, or 6.5, will not pay fees in FY 2012 due to 
fee waivers and reductions. Based on experience with the first 8 years 
of ADUFA, FDA believes that this is a reasonable basis for estimating 
the number of fee-paying establishments in FY 2012.
    Accordingly, the agency estimates that a total of 58.5 
establishments (65 minus 6.5) will be subject to establishment fees in 
FY 2012.

B. Establishment Fee Rates for FY 2012

    FDA must set the fee rates for FY 2012 so that the estimated 58.5 
establishments that pay fees will generate a total of $5,442,000. To 
generate this amount will require the fee for an animal drug 
establishment, rounded to the nearest 50 dollars, to be $93,050.

VII. Sponsor Fee Calculations for FY 2012

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The animal drug sponsor fee (also referred to as the sponsor fee) 
must be paid annually by each person who: (1) Is named as the applicant 
in an animal drug application, except for an approved application for 
which all subject products have been removed from listing under section 
510 of the FD&C Act or has submitted an investigational animal drug 
submission that has not been terminated or otherwise rendered inactive; 
and (2) had an animal drug application, supplemental animal drug 
application, or investigational animal drug submission pending at FDA 
after September 1, 2003. (See 21 U.S.C. 379j-11(6) and 379j-12(a)(4).) 
An animal drug sponsor is subject to only one such fee each fiscal 
year. (See 21 U.S.C. 379j-12(a)(4).) The sponsor fees are to be set so 
that they will generate $5,442,000 in fee revenue for FY 2012. This is 
the amount set out in the statute, and no adjustments are required for 
FY 2012.
    To set animal drug sponsor fees to realize $5,442,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2012. Based on the number of firms that would have met this 
definition in each of the past 8 years, FDA estimates that a total of 
172 sponsors will meet this definition in FY 2012.
    Careful review indicates that about one third or 33 percent of all 
of these sponsors will qualify for minor use/minor species waiver or 
reduction (21 U.S.C. 379j-12(d)(1)(C)). Based on the agency's 
experience to date with sponsor fees, FDA's current best estimate is 
that an additional 20 percent will qualify for other waivers or 
reductions, for a total of 53 percent of the sponsors invoiced, or 91, 
who will not pay fees in FY 2012 due to fee waivers and reductions. FDA 
believes that this is a reasonable basis for estimating the number of 
fee-paying sponsors in FY 2012.
    Accordingly, the agency estimates that a total of 81 sponsors (172 
minus 91) will be subject to and pay sponsor fees in FY 2012.

B. Sponsor Fee Rates for FY 2012

    FDA must set the fee rates for FY 2012 so that the estimated 81 
sponsors that pay fees will generate a total of $5,442,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest 50 dollars, to be $67,200.

VIII. Fee Schedule for FY 2012

    The fee rates for FY 2012 are summarized in table 2 of this 
document.

                       Table 2--FY 2012 Fee Rates
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                                                           Fee rate for
              Animal drug user fee category                   FY 2012
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Animal Drug Application Fees............................        $372,100
Animal Drug Application.................................
Supplemental Animal Drug Application for which Safety or         186,050
 Effectiveness Data are Required or Animal Drug
 Application Subject to the Criteria Set Forth in
 Section 512(d)(4) of the FD&C Act......................
Animal Drug Product Fee.................................           7,935

[[Page 45814]]

 
Animal Drug Establishment Fee \1\.......................          93,050
Animal Drug Sponsor Fee \2\.............................          67,200
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
  fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

IX. Procedures for Paying the FY 2012 Fees

A. Application Fees and Payment Instructions

    The appropriate application fee established in the new fee schedule 
must be paid for an animal drug application or supplement subject to 
fees under ADUFA that is submitted after September 30, 2011. Payment 
must be made in U.S. currency by check, bank draft, or U.S. postal 
money order payable to the order of the Food and Drug Administration, 
by wire transfer, or electronically using Pay.gov. (The Pay.gov payment 
option is available to you after you submit a cover sheet. Click the 
``Pay Now'' button.) On your check, bank draft, or U.S. postal money 
order, please write your application's unique Payment Identification 
Number (PIN), beginning with the letters AD, from the upper right-hand 
corner of your completed Animal Drug User Fee Cover Sheet. Also write 
the FDA post office box number (P.O. Box 953877) on the enclosed check, 
bank draft, or money order. Your payment and a copy of the completed 
Animal Drug User Fee Cover Sheet can be mailed to: Food and Drug 
Administration, P.O. Box 953877, St. Louis, MO 63195-3877.
    If payment is made by wire transfer, send payment to: U.S. 
Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, 
FDA Deposit Account Number: 75060099, U.S. Department of Treasury 
routing/transit number: 021030004, SWIFT Number: FRNYUS33. You are 
responsible for any administrative costs associated with the processing 
of a wire transfer. Contact your bank or financial institution 
regarding additional fees.
    If you prefer to send a check by a courier such as Federal Express 
(FEDEX) or United Parcel Service (UPS), the courier may deliver the 
check and printed copy of the cover sheet to: U.S. Bank, Attn: 
Government Lockbox 953877, 1005 Convention Plaza, St. Louis, MO 63101. 
(Note: This address is for courier delivery only. If you have any 
questions concerning courier delivery contact the U.S. Bank at 314-418-
4821. This telephone number is only for questions about courier 
delivery.)
    The tax identification number of the Food and Drug Administration 
is 530196965. (Note: In no case should the payment for the fee be 
submitted to FDA with the application.)
    It is helpful if the fee arrives at the bank at least a day or two 
before the application arrives at FDA's CVM. FDA records the official 
application receipt date as the later of the following: The date the 
application was received by FDA's CVM, or the date U.S. Bank notifies 
FDA that your payment in the full amount has been received, or when the 
U.S. Treasury notifies FDA of receipt of an electronic or wire transfer 
payment. U.S. Bank and the U.S. Treasury are required to notify FDA 
within one working day, using the PIN described previously.

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log on to the ADUFA 
Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and under Tools and Resources 
click ``The Animal Drug User Fee Cover Sheet'' and then click ``Create 
ADUFA User Fee Cover Sheet.'' For security reasons, each firm 
submitting an application will be assigned an organization 
identification number, and each user will also be required to set up a 
user account and password the first time you use this site. Online 
instructions will walk you through this process.
    Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it 
to FDA, and print a copy. After logging into your account with your 
user name and password, complete the steps required to create an Animal 
Drug User Fee Cover Sheet. One cover sheet is needed for each animal 
drug application or supplement. Once you are satisfied that the data on 
the cover sheet is accurate and you have finalized the cover sheet, you 
will be able to transmit it electronically to FDA and you will be able 
to print a copy of your cover sheet showing your unique PIN.
    Step Three--Send the payment for your application as described in 
section IX.A of this document.
    Step Four--Please submit your application and a copy of the 
completed Animal Drug User Fee Cover Sheet to the following address: 
Food and Drug Administration, Center for Veterinary Medicine, Document 
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.

C. Product, Establishment, and Sponsor Fees

    By December 31, 2011, FDA will issue invoices and payment 
instructions for product, establishment, and sponsor fees for FY 2012 
using this Fee Schedule. Payment will be due and payable within 30 days 
of issuance of the invoice. FDA will issue invoices in November 2012 
for any products, establishments, and sponsors subject to fees for FY 
2012 that qualify for fees after the December 2011 billing.

    Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19336 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P